NCT05505240

Brief Summary

The aim of this study is to investigate the influence of four different ambient temperatures (18, 22, 28, 38°C) on the resting energy expenditure of healthy adults by respiratory gas analysis. It is assumed that the resting energy expenditure is higher at 18°C and 38°C than at the temperatures in between.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

August 15, 2022

Last Update Submit

April 11, 2023

Conditions

Keywords

Resting energy expenditureResting metabolic rateAmbient temperatureEnvironmental temperature

Outcome Measures

Primary Outcomes (1)

  • Resting Energy Expenditure

    Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min

    20 minutes

Secondary Outcomes (4)

  • Body core temperature

    20 minutes

  • Body surface temperature

    20 minutes

  • Body composition

    5 minutes (after respiratory analysis)

  • Blood pressure

    10 minutes (at beginning of study day)

Study Arms (4)

Cold temperature

EXPERIMENTAL

18°C

Other: Respiratory analysis at cold temperature

Room temperature

EXPERIMENTAL

22°C

Other: Respiratory analysis at room temperature

Thermoneutral temperature

EXPERIMENTAL

28°C

Other: Respiratory analysis at thermoneutral temperature

Hot temperature

EXPERIMENTAL

38°C

Other: Respiratory analysis at hot temperature

Interventions

Respiratory analysis at an ambient temperature of 18°C

Cold temperature

Respiratory analysis at an ambient temperature of 22°C

Room temperature

Respiratory analysis at an ambient temperature of 28°C

Thermoneutral temperature

Respiratory analysis at an ambient temperature of 38°C

Hot temperature

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: 18,5 - 24,9 kg/m2
  • metabolically healthy

You may not qualify if:

  • smoking
  • low or high blood pressure
  • dyslipidemia
  • insulin resistance or diabetes mellitus type 1 or type 2
  • gastrointestinal diseases (e.g. food intolerances or allergies)
  • liver, kidney and/or thyroid diseases
  • hepatitis B or C, HIV Infection
  • chronic inflammatory diseases
  • disordered eating
  • psychological diseases
  • alcohol and/or drug abuse
  • use of medication
  • pregnancy or lactating
  • participation in another intervention study
  • women: irregular menstrual cycle
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn

Bonn, 53115, Germany

Location

Related Publications (1)

  • Henkel S, Frings-Meuthen P, Diekmann C, Coenen M, Stoffel-Wagner B, Nemeth R, Pesta D, Egert S. Influence of Ambient Temperature on Resting Energy Expenditure in Metabolically Healthy Males and Females. J Nutr. 2025 Mar;155(3):862-870. doi: 10.1016/j.tjnut.2025.01.013. Epub 2025 Jan 13.

Study Officials

  • Sarah Egert, Prof. PhD

    University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. PhD

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

November 21, 2022

Primary Completion

April 6, 2023

Study Completion

April 6, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations